Development of an Integrated Positron Emission Tomography/Magnetic Resonance (PET/MR) System, Accessories and Components

March 4, 2019 updated by: GE Healthcare

Development of an Integrated PET/MR System, Accessories and Components

The PET/MR device components and accessories are under development in order to optimize, validate and improve the design including improving the quality of images. The purpose of this study is:

  • Aim 1: Perform iterative evaluations of the device (including features and components) to optimize device performance and assess feasibility of new features;
  • Aim 2: Perform activities in support of design validation as needed for regulatory submission;
  • Aim 3: Evaluate device complaints and analyze potential causes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a non-randomized, non-statistically powered, single-site, prospective study designed to gather imaging data for design optimization, regulatory submission and future product development of an investigational hybrid PET/MRI scanner. Subjects will undergo a clinically indicated PET/CT exam subsequent to tracer administration. Once clinical imaging is complete, subjects will be transported to the PET/MR scanner at the General Electric (GE) Facility for additional imaging. No additional pharmaceuticals or ionizing radiation will be utilized as part of this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must have a clinical indication for a PET/CT exam
  • Subject must be at least eighteen (18) years of age; and
  • Subject must be able to hear and understand instructions without assistive devices; and
  • Subjects must be ambulatory, and able to walk 350 feet without any assistive devices and climb 2 steps; and
  • Subject must be able to provide identification with photograph; and
  • Female subjects with negative urine pregnancy test performed within 24 hours prior to the clinical PET/CT imaging; and
  • Subject must provide written informed consent; and
  • Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
  • Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
  • Subject must be able to participate in a PET/MR imaging session within 1 hour of concluding their PET/CT exam

Exclusion Criteria:

  • General Electric Healthcare (GEHC) employees; or
  • GEHC contractors; or
  • Healthcare providers (Any person in a position to purchase, lease, recommend, use, prescribe or arrange for the purchase or lease of any GEHC product or service that is reimbursable under any government program or private health insurance) or employees/contractors of medical device companies (as determined by self-report); or
  • Female subjects with known or suspected pregnancy; or
  • Subjects who have any axial diameter larger than 55 cm; or
  • Subjects with a weight greater than 227 kgs; or
  • Subjects who currently have, or have ever had a Cardiac Pacemaker or Defibrillator with implanted components; or
  • Subjects who are currently undergoing a gastrointestinal study involving swallowing of camera pill or similar device; or

  • Subjects who have any of the conditions below at the time of the scan session:

    • Prior negative experience or problem related to a previous MRI examination
    • Eye injury involving a metallic object
    • Potential for metal to be in body due to a previous injury involving metallic objects
    • Taking fertility medication or having fertility treatment
    • Cochlear, otologic or other ear implant
    • Insulin or other infusion pump
    • Implanted drug infusion device
    • Any type of prosthesis (eye, penile, etc)
    • Swan-Ganz or thermodilution catheter
    • Any metallic fragment or foreign body
    • Artificial or prosthetic limb
    • Bone/joint pin, screw, nail, wire, plate, etc
    • Neurostimulation system
    • Surgical staples, clips, or metallic sutures;
    • Implanted cardioverter defibrillator (ICD);
    • Magnetically activated implant or device;
    • Vascular access port and/or catheter;
    • Medication patch (Nicotine, Nitroglycerine);
    • Internal electrodes or wires;
    • External electronic medical device
    • Bone growth/bone fusion stimulator
    • Radiation seeds or implants
    • Heart valve prosthesis
    • Spinal cord stimulator
    • Eyelid spring or wire
    • Wire mesh implant
    • Tissue expander (e.g. breast)
    • Aneurysm clip(s)
    • Joint replacement (hip, knee, etc…)
    • Vascular or other stent(s), filter(s) or coil(s)
    • Intra-uterine device, diaphragm or pessary
    • Shunt (spinal or intraventricular)
    • Loose dental fillings
    • Dental fillings or crowns placed in the past 30 days
    • Tattoo or permanent makeup
    • Any implant
    • Breathing problem or motion disorder
    • Claustrophobia or panic attacks
    • Hearing Aid
    • Body piercing jewelry
    • Dentures or partial plates
    • External medical hardware (e.g. orthopedic braces)
    • Orthodontic appliances (e.g. braces, expanders)
    • Known or past allergic reactions to latex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Arm
Evaluation of PET MR device for image assessment and device performance
Device: PET MR Device
GE PET/MRI system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PET/MR Scan Obtained
Time Frame: One (1) day
One PET/MR scan per subject should be obtained. The scan images are evaluated by a subject matter expert for adequate diagnostic quality.
One (1) day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Complaints
Time Frame: One day
Number of device complaints reported during a scan
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GE Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Prost, PhD, Froedtert Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 114-2013-GES-0012

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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